K981613 is an FDA 510(k) clearance for the COBE SMARXT TUBING AND CONNECTORS. This device is classified as a Tubing, Pump, Cardiopulmonary Bypass (Class II - Special Controls, product code DWE).
Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on October 26, 1998, 173 days after receiving the submission on May 6, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4390.
| 510(k) Number | K981613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1998 |
| Decision Date | October 26, 1998 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWE — Tubing, Pump, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4390 |